Status
Terminated
Drug Enforcement D-1013-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Classification
Class II
Report Date
August 9, 2023
Termination Date
March 28, 2025
Product Information
- Product description
- oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
- Product quantity
- 2692 bags
- Reason for recall
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Address
-
2200 S 43rd Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1013-2023
- Event ID
- 92707
- Recall initiation date
- July 14, 2023
- Center classification date
- August 1, 2023
- Code info
- Lot: 36-241803, 36-241804, Exp. 7/21/2023; 36-243836, Exp. 7/31/2023; 36-246645, Exp. 8/3/2023; 36-246729, Exp. 8/6/2023; 36-248976, Exp. 8/16/2023; 36-249502, Exp. 8/17/2023; 36-252215, 8/31/2023; 36-255872, 36-255875, Exp. 9/10/2023
- More code info
- —